Superdimension/Bronchus Premium

• • Terminated Z-0666-2007 FDA Unclassified (pre-2012) ·initiated 29 Nov 2006

  The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.

510(k) Number

K052852 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Superdimension Nitinol/Gold Fiducial Marker

  Class II

  FDA 510(k) K120796 Active Cleared 26 Oct 2012

• Inreach System

  Class II

  FDA 510(k) K080271 Active Cleared 31 Mar 2008

• Superdimension Marker Delivery Kit

  Class II

  FDA 510(k) K110093 Active Cleared 11 Feb 2011

• Modification to Inreach System

  Class II

  FDA 510(k) K081379 Active Cleared 11 Jun 2008

• Modification to Superdimension/Bronchus Premium 2

  Class II

  FDA 510(k) K071473 Active Cleared 12 Jul 2007

• I-Logic Inreach System

  Class II

  FDA 510(k) K102604 Active Cleared 7 Oct 2010

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